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FDA 510(k) Application Details - K031490
Device Classification Name
Latex Agglutination Assay, Rubella
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510(K) Number
K031490
Device Name
Latex Agglutination Assay, Rubella
Applicant
IMMUNOSTICS, INC.
3505 SUNSET AVE.
OCEAN, NJ 07712 US
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Contact
JEFFREY FLEISHMAN
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Regulation Number
866.3510
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Classification Product Code
LQN
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More FDA Info for this Product Code
Date Received
05/12/2003
Decision Date
07/16/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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